Thymic carcinoma
Conditions
Interventions
Sponsors
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age 18 years or above; 2.Pathologically diagnosed with thymic cancer, clinical stage III-IVa (AJCC, 9th); 3.After multidisciplinary MDT discussion, it is determined that there is potential for resectability; 4.Has not received local and systemic treatment targeting primary thymic cancer before; 5.Has at least one measurable lesion (RECIST V1.1); 6.ECOG PS is 0 or 1; 7.Expected lifespan is >= 3 months; 8.The functional levels of organs must meet the following requirements: ANC >=1.5×10^9/L; PLT >=90×10^9/L; Hb>=90 g/L; TBIL = 50 mL/min (Cockcroft-Gault formula); LVEF >= 50%; Fridericia method-corrected QT interval (QTcF) for males < 450 ms, females < 470 ms; INR <= 1.5×ULN, ACTT <= 1.5×ULN. 9.Pregnant women of childbearing age must undergo a serum pregnancy test 7 days before the first administration of the study drug, and the result must be negative. Male participants of pregnant women subjects and their partners who are of childbearing age must agree to use contraception from the date of signing the informed consent form until 24 weeks after the last administration of the study drug; 10.Participants voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1.Pathological diagnosis: Thymic neuroendocrine tumor; 2.Currently participating in an interventional clinical study for treatment, or having received other investigational drugs or used investigational devices within 4 weeks prior to the first administration; 3.Allergic to any component of the investigational drug; 4.Having clinical symptoms requiring clinical intervention such as pericardial effusion, pleural effusion, or peritoneal effusion; 5.Active brain metastasis; patients with asymptomatic brain metastasis can be enrolled; for patients with clinically suspected central nervous system metastasis, CT/MRI examination must be conducted within 28 days before enrollment to rule out central nervous system metastasis; 6.History of unstable angina pectoris; those diagnosed with angina pectoris within 3 months before screening or having experienced a myocardial infarction event within 6 months before screening; arrhythmia (including QTcF: men >= 450 ms, women >= 470 ms) requires long-term use of anti-arrhythmic drugs and NYHA classification >= II grade heart dysfunction; 7.Urinalysis indicates urine protein >= ++ and 24-hour urine protein quantification > 1.0 g has been confirmed; 8.History of sarcoidosis or tuberculosis; 9.Active hepatitis B or hepatitis C history and HIV infection patients; 10.Active autoimmune diseases or immunodeficiency, or having the above history, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain-Barré syndrome, or multiple sclerosis, etc. 11.Serious infections that occurred within 4 weeks prior to the start of the treatment, including but not limited to infection complications requiring hospitalization, bacteremia, severe pneumonia, etc.; 12.Administration of therapeutic oral or injectable antibiotics within 2 weeks prior to the start of the treatment; 13.Pregnancy or lactation or potential pregnancy during the treatment period or within 6 months after the last medication administration; 14.Individuals with bleeding tendencies or significant evidence of coagulation disorders (not receiving anticoagulant therapy); 15.Severe, non-healing or ruptured wounds, active ulcers or untreated fractures; 16.Percutaneous needle biopsy or other minor surgeries performed within 3 days before the first medication administration, excluding the placement of vascular access devices; 17.Major surgeries performed within 4 weeks prior to the first medication administration, or expected to be required during the treatment period; 18.Use of systemic immunosuppressive drugs within 2 weeks prior to the first medication administration (including but not limited to glucocorticoids [> 10 mg/d prednisone or equivalent pharmacological doses of other corticosteroids], cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor-a [TNF-a] preparations), or expected to be required during the treatment period; 19.Subjects who have received or are expected to receive live vaccines within 30 days before the first medication administration, or those who need to use the vaccine during the treatment period or within 5 months after the last medication administration; 20.Concurrently suffering from other malignant tumors that are progressive or require active treatment. 21.Those who have a history of substance abuse involving psychotropic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Major Pathological response;Objective response rate;Safety;Event-free survival;R0 resection rate;Disease Control Rate; | — |
Countries
China
Contacts
Public ContactWen Gao
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed